AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Anastomotic Leakage Prevention by Endovascular Stenting of the Superior Mesenteric Artery

RecruitingNAAges 40 Years - anyAllMedisch Spectrum Twente
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

Rationale: Anastomotic leakage (AL) is a severe complication of colon surgery, with an incidence of 2.7-11.9%. It is associated with long-term increased mortality, reduced quality of life, and high healthcare costs due to reoperations and prolonged hospitalization. Among colon cancer patients, 5-year survival rates are 70% for those with AL compared to 81% for those without. A retrospective case-control study identified a \>50% stenosis of the Superior Mesenteric Artery (SMA) as a significant risk factor, increasing AL odds by six times (OR: 5.9, 95% CI: 2.7-12.6, p \< .001). Primary objective: The ALPrES2MA study aims to evaluate whether preventive endovascular stenting of a \>50% stenosed SMA origin reduces the risk of AL following colon surgery. Secondary objectives: Classification of severity of AL, incidence of delayed AL (\>90 days), Mesenteric Artery Calcification Score (MACS

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age \>40 years. * Patient scheduled for elective colon resection above the recto-sigmoid junction with a primary anastomosis (side-to-side, side-to-end, or end-to-end). * Presence of an asymptomatic \>50% atherosclerotic origin stenosis of the superior mesenteric artery (SMA) Exclusion Criteria: * All patients with symptomatic chronic or acute mesenteric ischemia (i.e., mesenteric artery stenosis in combination with symptoms as postprandial abdominal pain, fear of eating, altered eating patterns, weight loss, diarrhoea, nausea, or exercise-induced abdominal pain). * Presence of a \>50% stenosis of the celiac artery, regardless of the underlying pathology (i.e., intra-articular atherosclerosis, intra articular thrombus or external compression by the median accurate ligament). * Simultaneous performed during the colon resection: a substantial abdominal organ resection, or T4b/T4c colon tumour resection, or a second colon anastomosis or a diverting stoma * History of mesenteric revascularization, including endovascular stenting, thrombectomy, or bypass surgery involving any of the mesenteric arteries * Patients with a history of heparin induced thrombocytopenia-type 2 due to contraindication for VBX Stent Graft. * Patients with a contra-indication for mono antiplatelet therapy with Ascal due to comorbidities, allergy or intolerance. * Pregnancy
๐Ÿ’Š

What it tests

  • Percutaneous transluminal angiopasty and endovascular stenting of the superior mesenteric artery
  • Colon surgery
  • Mono antiplatelet therapy with Ascal 80mg daily
๐Ÿ“

Where

18 sites
Treant
Emmen, Netherlands
Meander
Amersfoort, Netherlands
Gelre ziekenhuis
Apeldoorn, Netherlands
Zuyderland
Heerlen, Netherlands
Maastricht Universitair Medisch Centrum (MUMC+)
Maastricht, Netherlands
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Spaarne Gasthuis
Haarlem, Netherlands

โ€ฆand 10 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy